Incidence and Risk Factors of Low Anterior Resection Syndrome

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT06359730
• Lead Sponsor: Zagazig University

Brief Summary

Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.

With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-07
• Last Update Submitted: 2024-04-07
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age more than 18

  • Diagnosed patients with rectal adenocarcinoma and who received low anterior resection with anastomosis creation or after a minimum 6 months interval after stoma reversal.
  • Tumors of the rectum (2-15 cm) from anal verge

Exclusion Criteria

• • cognitive dysfunction

  • Having a history of inflammatory bowel disease or any disease with bowel function impairment namely, Crohn's disease, irritable bowel syndrome, ulcerative colitis or others.
  • Age less than 18
  • Metastatic cancer or tumor recurrence
  • Rectal tumors within 2 cm from anal verge( abdominoperineal)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
type of surgery	from 2017 to 2022	from records; surgery was open or laparoscopic
site of tumor	from 2017 to 2022	tumor site was determined in Cm from anal verge by colonoscopy
site of anastmosis	from 2017 to 2022	site of anastmosis after resection was recorded as colo-rectal or colo-anal
type of meso-rectal excision	from 2017 to 2022	excision of meso-rectum was recorded if it was partial or complete
age	from 2017 to 2022	age of the patients in years was recorded from patient records
sex	from 2017 to 2022	sex of patients was recorded from patient records
type of anastmosis	from 2017 to 2022	type of anastmosis(hand sewen or stappled) obtained from records
LARS score	from 2017 to 2022	obtained by LARS questionnaire filled by the patient during follow up, it was formed of five questions with different scores on answer choices, interpretaion (0-20) means no LARS, (21- 29) means minor LARS, (30-42) means major LARS
medical disease	from 2017 to 2022	medical disease like diabetes and hypertension was recorded from patient records
adjuvant therapy	from 2017 to 2022	it was recorded from patients records if he\\she had chemo- or radiotherapy post-operatively
neoadjuvant therapy	from 2017 to 2022	history of neoadjuvant therapy before surgery was obtained from patients records

Trial Locations

Locations (1)

Zagazig University Hospitals; 🇪🇬 Zagazig, Egypt